Anne-Marie Eades

Patients’ and Providers’ Perspectives of a Polypill Strategy to Improve Cardiovascular Prevention in Australian Primary Health Care A Qualitative Study Set Within a Pragmatic Randomized, Controlled Trial

Background—This study explores health provider and patient attitudes toward the use of a cardiovascular polypill as a health service strategy to improve cardiovascular prevention. Methods and Results—In-depth, semistructured interviews (n=94) were conducted with health providers and patients from Australian general practice, Aboriginal community-controlled and government-run Indigenous Health Services participating in a pragmatic randomized controlled trial evaluating a polypill-based strategy for high-risk primary and secondary cardiovascular disease prevention. Interview topics included polypill strategy acceptability, factors affecting adherence, and trial implementation. Transcribed interview data were analyzed thematically and interpretively. Polypill patients commented frequently on cost-savings, ease, and convenience of a daily-dosing pill. Most providers considered a polypill strategy to facilitate improved patient medication use. Indigenous Health Services providers and indigenous patients thought the strategy acceptable and beneficial for indigenous patients given the high disease burden. Providers noted the inflexibility of the fixed dose regimen, with dosages sometimes inappropriate for patients with complex management considerations. Future polypill formulations with varied strengths and classes of medications may overcome this barrier. Many providers suggested the polypill strategy, in its current formulations, might be more suited to high-risk primary prevention patients. Conclusions—The polypill strategy was generally acceptable to patients and providers in cardiovascular prevention. Limitations to provider acceptability of this particular polypill were revealed, as was a perception it might be more suitable for high-risk primary prevention patients, though future combinations could facilitate its use in secondary prevention. Participants suggested a polypill-based strategy as particularly appropriate for lowering the high cardiovascular burden in indigenous populations. Clinical Trial Registration—URL: http://www.anzctr.org.au. ANZCTRN: 12608000583347.

The health-related quality of life of Indigenous populations: a global systematic review

PurposeIndigenous conceptions of health have been shown to differ from that of their non-Indigenous counterparts. As a result, there remains uncertainty over the appropriateness and value of using existing health-related quality-of-life (HRQoL) instruments in Indigenous communities. The objective of this review was to identify studies that either measure the HRQoL of an Indigenous population or validated a measure used to elicit the HRQoL in an Indigenous population.MethodsA systematic review of the published literature was conducted to (1) investigate the extent to which HRQoL instruments are used in Indigenous populations; (2) to identify which instruments have been validated in which populations; and (3) to identify which instruments have been tailored for use with Indigenous populations.ResultsForty-one studies were included in the review. Only three of the 41 studies utilised Indigenous-specific instruments. The remainder (38 studies) utilised generic population or disease-specific instruments. Four studies found specific HRQoL instruments to be valid in these populations and 32 estimated the HRQoL of an Indigenous population. The limited examples of Indigenous-specific instruments highlighted the potential importance to the HRQoL of these populations of domains that lie outside of traditional measures including social and community domains as well as domains relating to culture, diet and land use on top of more traditional HRQoL domains.ConclusionEnsuring that the HRQoL of Indigenous populations is being appropriately measured is vital to prioritising available resources to the most effective interventions. HRQoL instruments present an opportunity to directly elicit and incorporate Indigenous preferences and conceptions of health into these decisions. Further work is required in the field to ensure that this potential is realised.

Global systematic review of Indigenous community-led legal interventions to control alcohol

Objectives The national and subnational governments of most developed nations have adopted cost-effective regulatory and legislative controls over alcohol supply and consumption with great success. However, there has been a lack of scrutiny of the effectiveness and appropriateness of these laws in shaping the health-related behaviours of Indigenous communities, who disproportionately experience alcohol-related harm. Further, such controls imposed unilaterally without Indigenous consultation have often been discriminatory and harmful in practice. Setting, participants and outcome measures In this systematic review of quantitative evaluations of Indigenous-led alcohol controls, we aim to investigate how regulatory responses have been developed and implemented by Indigenous communities worldwide, and evaluate their effectiveness in improving health and social outcomes. We included articles from electronic databases MEDLINE, EMBASE, CINAHL, PsycINFO and Web of Science from inception to December 2015. Results Our search yielded 1489 articles from which 18 met the inclusion criteria. Controls were implemented in rural and remote populations of high-income nations. Communities employed a range of regulatory options including alcohol rationing, prohibition of sale, importation or possession, restrictions on liquor sold, times of sale or mode of sale, Indigenous-controlled liquor licensing, sin tax and traditional forms of control. 11 studies reported interventions that were effective in reducing crime, injury deaths, injury, hospitalisations or lowering per capita consumption. In six studies interventions were found to be ineffective or harmful. The results were inconclusive in one. Conclusions Indigenous-led policies that are developed or implemented by communities can be effective in improving health and social outcomes.

Implementing Kanyini GAP, a pragmatic randomised controlled trial in Australia: findings from a qualitative study

BackgroundPragmatic randomised controlled trials (PRCTs) aim to assess intervention effectiveness by accounting for ‘real life’ implementation challenges in routine practice. The methodological challenges of PRCT implementation, particularly in primary care, are not well understood. The Kanyini Guidelines Adherence to Polypill study (Kanyini GAP) was a recent primary care PRCT involving multiple private general practices, Indigenous community controlled health services and private community pharmacies. Through the experiences of Kanyini GAP participants, and using data from study materials, this paper identifies the critical enablers and barriers to implementing a PRCT across diverse practice settings and makes recommendations for future PRCT implementation.MethodsQualitative data from 94 semi-structured interviews (47 healthcare providers (pharmacists, general practitioners, Aboriginal health workers; 47 patients) conducted for the process evaluation of Kanyini GAP was used. Data coded to ‘trial impact’, ‘research motivation’ and ‘real world’ were explored and triangulated with data extracted from study materials (e.g. Emails, memoranda of understanding and financial statements).ResultsPRCT implementation was facilitated by an extensive process of relationship building at the trial outset including building on existing relationships between core investigators and service providers. Health providers’ and participants’ altruism, increased professional satisfaction, collaboration, research capacity and opportunities for improved patient care enabled implementation. Inadequate research infrastructure, excessive administrative demands, insufficient numbers of adequately trained staff and the potential financial impact on private practice were considered implementation barriers. These were largely related to this being the first experience of trial involvement for many sites. The significant costs of addressing these barriers drew study resources from the task of achieving recruitment targets.ConclusionsConducting PRCTs is crucial to generating credible evidence of intervention effectiveness in routine practice. PRCT implementation needs to account for the particular challenges of implementing collaborative research across diverse stakeholder organisations. Reliance on goodwill to participate is crucial at the outset. However, participation costs, particularly for organisations with little or no research experience, can be substantial and should be factored into PRCT funding models. Investment in a pool to fund infrastructure in the form of primary health research networks will offset some of these costs, enabling future studies to be implemented more cost-effectively.Trial registrationACTRN126080005833347

Facilitators and barriers to implementation of a pragmatic clinical trial in Aboriginal health services

Objective: To identify facilitators and barriers to clinical trial implementation in Aboriginal health services.

Australian Aboriginal and Torres Strait Islander-focused primary healthcare social and emotional wellbeing research: a systematic review protocol

BackgroundResearch with a focus on Aboriginal and Torres Strait Islander Australian’s (hereafter referred to as Indigenous1) needs is crucial to ensure culturally appropriate evidence-based strategies are developed to improve health. However, concerns surrounding this research exist, arising from some previous research lacking community consultation, resulting in little community benefit or infringing on important cultural values. Values and Ethics: Guidelines for Ethical conduct in Aboriginal and Torres Strait Islander Health Research (hereafter referred to as Values and Ethics), developed by The National Health and Medical Research Council of Australia in 2003, is the ethical standard for Indigenous-focused health research. Researchers must address its Values in research design and conduct. However, its impact on research processes is unclear. Local Protocols should also be considered. This review aims to systematically examine practices related to Values and Ethics, Local Protocols and the processes of conducting Indigenous-focused primary healthcare research in collaboration with external researchers.MethodsThe following electronic databases and grey literature will be searched (2003 to current): MEDLINE, EMBASE, CINAHL, Informit and HealthInfoNet—an Indigenous-specific research and program website. Indigenous-focused research will be included. Research must be conducted in one or more primary healthcare services, in collaboration with external researchers and with a focus on social and emotional well being. One reviewer will review titles and abstracts to remove obviously irrelevant research articles. Full-text research articles will be retrieved and independently examined by two reviewers. Data and quality assessment will be completed by one reviewer and verified by a second reviewer. Quality will be assessed using modified versions of established quality assessment tools.DiscussionThis review will provide information on research processes and the impact of Values and Ethics on Indigenous-focused primary healthcare research, informing communities and primary healthcare staff around research practices, and researchers and policy makers of strengths and weaknesses of practice.Systematic review registrationPROSPERO CRD42015024994

Generating sustainable collective action: Models of community control and governance of alcohol supply in Indigenous minority populations

Restrictions on the supply of alcohol are amongst the most effective and cost effective interventions to address harmful use. However, despite international human rights bodies recognising that self determination must be pre-eminent in efforts to improve Indigenous health, little is known about the role of Indigenous communities in designing and implementing alcohol controls as well as the degree to which government resourcing and/or regulation is utilised. This commentary explores Australian examples of the governance models used to ensure Indigenous participation and leadership when developing regulatory interventions for alcohol control within communities. We identify four models of Indigenous governance: alcohol control interventions that were community conceived and implemented, government-facilitated community-led, community coalitions backed by government intervention and government initiated community partnerships. Each model is underpinned by specific governance arrangements which incorporate rules and processes that determine authority, accountability and Indigenous participation in decision-making. The aim of this paper is to benchmark these models of governance along a spectrum of community engagement beginning with forms of non-participation and ending with full citizen control. In addition, we put forward recommendations for governments at all levels to facilitate culturally acceptable and robust models of Indigenous governance that have the potential to improve health and social outcomes.

Process evaluation of a primary healthcare validation study of a culturally adapted depression screening tool for use by Aboriginal and Torres Strait Islander people: study protocol

Introduction Process evaluations are conducted alongside research projects to identify the context, impact and consequences of research, determine whether it was conducted per protocol and to understand how, why and for whom an intervention is effective. We present a process evaluation protocol for the Getting it Right research project, which aims to determine validity of a culturally adapted depression screening tool for use by Aboriginal and Torres Strait Islander people. In this process evaluation, we aim to: (1) explore the context, impact and consequences of conducting Getting It Right, (2) explore primary healthcare staff and community representatives’ experiences with the research project, (3) determine if it was conducted per protocol and (4) explore experiences with the depression screening tool, including perceptions about how it could be implemented into practice (if found to be valid). We also describe the partnerships established to conduct this process evaluation and how the national Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research is met. Methods and analysis Realist and grounded theory approaches are used. Qualitative data include semistructured interviews with primary healthcare staff and community representatives involved with Getting it Right. Iterative data collection and analysis will inform a coding framework. Interviews will continue until saturation of themes is reached, or all participants are considered. Data will be triangulated against administrative data and patient feedback. An Aboriginal and Torres Strait Islander Advisory Group guides this research. Researchers will be blinded from validation data outcomes for as long as is feasible. Ethics and dissemination The University of Sydney Human Research Ethics Committee, Aboriginal Health and Medical Research Council of New South Wales and six state ethics committees have approved this research. Findings will be submitted to academic journals and presented at conferences. Trial registration number ACTRN12614000705684.